Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID b906ec41-4049-43df-9ef3-ea71225cc910
Route
ORAL
Published
Effective Date 2023-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bos Taurus Adrenal Gland (6 [hp_X]) Pork Liver (8 [hp_X]) Toxicodendron Pubescens Leaf (12 [hp_X]) Urtica Dioica (16 [hp_X]) Rhus Aromatica Root Bark (15 [hp_C]) Rhus Glabra Top Histamine Toxicodendron Diversilobum Leaf Corticotropin
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2023-03-29 Until 2028-04-25

Description

Glandula Suprarenalis (Bovine) 6X, 12X, Hepar Suis (Liver) 6X, 12X, Rhus Tox (Poison Ivy) 6X, 12X, 60X, 100X, Urtica Dioica (Stinging Nettle) 6X, 12X, 60X, 100X, Rhus Aromatica (Fragrant Sumac) 8X, 12X, 60X, 100X, Rhus Glabra 8X, 12X, 60X, 100X, Histaminum Hydrochloricum 12X, Rhus Diversiloba (Pacific Poison Oak) 16X, 30X, 60X, 100X, Adrenocorticotrophin 15C, 30C.

Purpose

Provides factors that mitigate hypersensitivity to poison ivy and poison oak. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Provides factors that mitigate hypersensitivity to poison ivy and poison oak. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Glandula Suprarenalis (Bovine) 6X, 12X, Hepar Suis (Liver) 6X, 12X, Rhus Tox (Poison Ivy) 6X, 12X, 60X, 100X, Urtica Dioica (Stinging Nettle) 6X, 12X, 60X, 100X, Rhus Aromatica (Fragrant Sumac) 8X, 12X, 60X, 100X, Rhus Glabra 8X, 12X, 60X, 100X, Histaminum Hydrochloricum 12X, Rhus Diversiloba (Pacific Poison Oak) 16X, 30X, 60X, 100X, Adrenocorticotrophin 15C, 30C.

Purpose:

Provides factors that mitigate hypersensitivity to poison ivy and poison oak.

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

Professional Use Only

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

Questions:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

Directions:

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

Indications:

Provides factors that mitigate hypersensitivity to poison ivy and poison oak.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients:

Glandula Suprarenalis (Bovine) 6X, 12X, Hepar Suis (Liver) 6X, 12X, Rhus Tox (Poison Ivy) 6X, 12X, 60X, 100X, Urtica Dioica (Stinging Nettle) 6X, 12X, 60X, 100X, Rhus Aromatica (Fragrant Sumac) 8X, 12X, 60X, 100X, Rhus Glabra 8X, 12X, 60X, 100X, Histaminum Hydrochloricum 12X, Rhus Diversiloba (Pacific Poison Oak) 16X, 30X, 60X, 100X, Adrenocorticotrophin 15C, 30C.

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Package Label Display:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0039-1

POISON IVY &

OAK FORMULA

2 FL. OZ (60 ml)

Keep Out of Reach of Children:

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.


Structured Label Content

Purpose: (PURPOSE:)

Provides factors that mitigate hypersensitivity to poison ivy and poison oak.

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings: (WARNINGS:)

Professional Use Only

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

Questions: (QUESTIONS:)

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

Directions: (DIRECTIONS:)

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

Provides factors that mitigate hypersensitivity to poison ivy and poison oak.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients: (ACTIVE INGREDIENTS:)

Glandula Suprarenalis (Bovine) 6X, 12X, Hepar Suis (Liver) 6X, 12X, Rhus Tox (Poison Ivy) 6X, 12X, 60X, 100X, Urtica Dioica (Stinging Nettle) 6X, 12X, 60X, 100X, Rhus Aromatica (Fragrant Sumac) 8X, 12X, 60X, 100X, Rhus Glabra 8X, 12X, 60X, 100X, Histaminum Hydrochloricum 12X, Rhus Diversiloba (Pacific Poison Oak) 16X, 30X, 60X, 100X, Adrenocorticotrophin 15C, 30C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0039-1

POISON IVY &

OAK FORMULA

2 FL. OZ (60 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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